Class 2 Device Recall Fresenius 2008 Series Hemodialysis Machines

• Date Initiated by Firm: November 12, 2013
• Date Posted: January 06, 2014
• Recall Status: Terminated on March 26, 2019
• Recall Number: Z-0629-2014
• Recall Event ID: 66622
• 510(K)Number: K921456 K994267 K070049 K093902
• Product Classification: Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
• Product: Fresenius 2008 Series Hemodialysis Machines:; Models: 2008H, 2008K, 2008K2, 2008k@Home, 2008T; ; The 2008H Hemodialysis machine is indicated for acute and chronic dialysis therapy. Hemodialysis is indicated for patients with acute or chronic renal failure, when conservative therapy is judged to be inadequate. The dialysate delivery machine is used for hemodialysis in hospital, dialysis centers, and at home. The 2008K, 20081(2 and 2008T hemodialysis machines are designed to perform hemodialysis in hospitals and dialysis clinics. They can be used for patients suffering chronic or acute renal failure. The 2008K, 2008K2 and 2008T are designed to provide hemodialysis treatment by controlling and monitoring both the dialysate and extracorporeal blood circuits. The Fresenius 2008K~home is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K~home is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician.
• Code Information: All serial numbers
• Recalling Firm/ Manufacturer: Fresenius Medical Care Holdings, Inc.; 920 Winter St; Waltham MA 02451-1521
• For Additional Information Contact: 800-662-1237
• Manufacturer Reason for Recall: 2008 Series Hemodialysis Machines complaints of saline bags inappropriately filling during recirculation and setup
• FDA Determined Cause: Under Investigation by firm
• Action: Fresenius Medical issued a Product Notification letter dated November 12, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers who encounter a saline bag that is inappropriately filling, should discontinue the setup and remove the machine from service until the drain line and drain-associated hydraulic components can be checed by a qualified service technician. Customers were also instructed to ensure that the hemodialysis machine is installed and operated in compliance with the Machine Specification section of their operator's manual, including the specification located in the Water/Drain Section. Customers with questions were instructed to call 1-800-227-2572. For questions regarding this recall call 800-662-1237.
• Quantity in Commerce: 111,504 units US and 3,638 Canada and Mexico-
• Distribution: Worldwide Distribution - USA (nationwide) and Internationally Mexico and Canada.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KDI and Original Applicant = FRESENIUS MEDICAL CARE; 510(K)s with Product Code = KDI and Original Applicant = FRESENIUS MEDICAL CARE NORTH AMERICA; 510(K)s with Product Code = KDI and Original Applicant = FRESENIUS USA, INC.